DANA REUSABLE BI TEST PACK— 510(k) K130135

Substantially Equivalent

Dana Products, Inc.

FDA 510(k) clearance K130135 for DANA REUSABLE BI TEST PACK, Substantially Equivalent on 2013-11-25. Applicant: Dana Products, Inc.. Device class: 2.

Clearance details

Applicant: Dana Products, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2013-01-18
Decision date: 2013-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Barrington, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.